Senior Regulatory Affairs Specialist (Beijing) - Beijing - Stryker Corporation

Date de publication : 10/2/2019

Résumé de l'offre

Description de l'offre

Position summary:

This position is to ensure overall management of regulatory affairs and quality control on process and products are in compliance with government requirements and Stryker policy & standards. The role develops and implements clinical affair strategies so Stryker will build a strong branding and long term relationship with the medical industry.

Essential Duties & Responsibilities: (Detailed Description)

  • Prioritize, plan, and review product registrations for respective product lines
  • Prepare, coordinate and submit regulatory applications to the local health authority
  • Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. 
  • Provide the management team with regular updates on product registration.
  • Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education
  • Lobby with local health authorities using constructive/scientific challenges to regulations.  This should include guidance on alternative solutions to country regulatory needs
  • Support tender operations by timely supply of accurate regulatory documents
  • Establish relationships with local medical device industry groups and work with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
  • Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
  • Serve as regulatory consultant to marketing team and government regulatory agencies

Education & Experience:

  • Bachelor degree in Medicine or Bioengineering or above preferred.
  • Relevant regulatory and quality assurance experiences in international company for more than 2 years

Physical & Mental Requirements:

  • Well-organized and logical thinking
  • Good at planning and business processes,
  • Detailed oriented
  • Professional communication skills
  • Patience and a great sense of responsibility

Work From Home: No

Travel Percentage: 10%

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